Kornimate/medical-research-clean huggingface dataset:
a study to assess the efficacy and safety of mstt1041a in participants with uncontrolled severe asthma

Conditions: Asthma

Summary: this is a phase iib, randomized, placebo-controlled, double-blind, multicenter, multi-arm study which will evaluate efficacy, safety, and pharmacokinetic of mstt1041a compared with placebo as add-on therapy in participants with severe, uncontrolled asthma who are receiving medium- or high-dose inhaled corticosteroid (ics) therapy and at least one of the following additional controller medications: long-acting beta-agonists (laba), leukotriene modifier (ltm), long-acting muscarinic antagonist (lama), or long-acting theophylline preparation. the total duration of this study for each participant is approximately 70 weeks including screening, run-in, treatment, and follow-up.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18 to 38 kilogram/square meter (kg/m\^2) and weight \>= 40 kg at screening * documented physician-diagnosed asthma * on high dose inhaled corticosteroid (ics) therapy plus at least one additional allowed controller medication * forced expiratory volume in 1 second (fev1) of 40% to 80% of predicted * evidence of uncontrolled asthma * use of contraceptive measures exclusion criteria: * diagnosis of mimics of asthma * diagnosis of occupational asthma, aspirin-sensitive asthma, asthma chronic obstructive pulmonary disease overlap syndrome, or bronchiolitis, as determined by the investigator * pregnant or lactating, or intending to become pregnant during the study or within 20 weeks after the last dose of mstt1041a * recent history of smoking * history or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, have an impact on the study results * asthma exacerbation within 4 weeks prior to screening * intubation for respiratory failure due to asthma within 12 months prior to screening * comorbid conditions that may interfere with evaluation of investigational medicinal product * known sensitivity to any of the active substances or their excipients to be administered during dosing * positive pregnancy test
thalidomide in the treatment of chronic plaque psoriasis.

Conditions: Psoriasis, Plaque-type

Summary: the objective of this study is to obtain information on the effectiveness of thalidomide in psoriasis.


Eligibility criteria:
inclusion criteria: * male or female subjects 18 years of age or older. * stable or worsening psoriasis that involves 5% or greater of total body surface area (bsa) involvement with a minimum pasi score of 8. * moderate to severe plaque-type psoriasis, defined by a minimum score of 1 for each of erythema, scaling, and plaque thickness (using a 0 - 4 scale). * patients receiving systemic retinoids, prednisone, methotrexate, or cyclosporine should be on a stable dose at least 28 days prior to the first dose of thalidomide. * patients receiving topical treatments should be consistent with such treatments throughout the study. * the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study. * the ability to understand and sign a written informed consent form, which must be obtained prior to treatment. * the ability to understand, agree to, and comply with the requirements of the system for thalidomide education and prescribing safety (s.t.e.p.s.).\*\* (\*because of the known teratogenic effects of thalidomide and in an effort to prevent to the greatest extent possible any chance of fetal exposure to thalidomide, thalomid(thalidomide) is approved for marketing only under a special restricted distribution program approved by the fda. under this program, the system for thalidomide education and prescribing safety (s.t.e.p.s.), only prescribers and pharmacists registered with the program are allowed to prescribe and dispense thalidomide (zeldis jb et al. 1999). in addition, patients must be advised of, agree to, and comply with the requirements of the s.t.e.p.s. program. to monitor patient compliance with the s.t.e.p.s. program, all patients must complete the s.t.e.p.s. program informed consent and participate in a mandatory and confidential surveillance registry.) exclusion criteria: * unstable psoriasis * unable or unwilling to meet all criteria for contraception as required in steps. * known allergy to thalidomide. * known history of neuropathy. * abnormal laboratory test results that the investigator feels would compromise patient safety or evaluation of drug safety. * the introduction of drugs for other medical conditions which are known to affect psoriasis (e.g., lithium, beta-adrenergic blockers, etc.) during the period 4 weeks prior to and during the study period. * use of any investigational therapy within the 4 weeks prior to the first dose of thalidomide. * expectation of exposure to strong sunlight during the course of the study (e.g. planned holiday in high sunlight area) or intention of sunbathing for prolonged periods of time during the course of the study. * current drug or alcohol abuse (drug screening not required). * medical conditions that preclude thalidomide therapy. any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
agmt metastatic colorectal cancer registry (mcrc) third line and beyond

Conditions: Metastatic Colorectal Cancer (mCRC)

Summary: colorectal cancer (crc) is the second leading cause of cancer-related death in the united states and europe. although selected patients with oligometastatic crc undergo systemic therapy and surgery/local ablative therapy in curative intent, the treatment approach for the majority of metastatic crc (mcrc) patients remains palliative with a median overall survival (os) ranging between 9-38 months depending on various prognostic and predictive factors. particularly in advanced stages (in the third line of therapy and beyond), interesting and promising results have recently been achieved with various treatment approaches. the aim of this registry is to establish a disease-specific registry to evaluate the treatment landscape of patients with mcrc who have already received at least two lines of therapy.

this registry aims at retrospectively and prospectively evaluating the treatment landscape and clinical outcome of mcrc ≥3l in a collective attempt by including multiple oncologic centers in austria. patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. imaging studies ≥3l will be centrally collected in a virtual "imaging-bank" and tumor tissue samples of deceased patients will be stored in a central "bio-bank". additionally, further biomaterial (e.g. ctdna samples or dna from dpyd genotyping) may be requested from the centres in case of specific research questions. the patient follow-up data will be obtained until patient death or loss to follow-up. for documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. participation in the registry must not interfere with treatment routines. only routine data, which have already been recorded in the patients' medical charts, is transferred to the electronic case report forms. to maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patients' medical and other registry information throughout the lifetime of the registry. a written consent must be obtained prior to the input of data. no informed consent is required from deceased patients. data will be collected from all sites willing to participate.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years with tissue-based diagnosis of mcrc * ≥ 2 prior lines of palliative systemic therapy including 5-fu, irinotecan, oxaliplatin, anti-vegf, anti-egfr (in case of ras/braf wildtype), anti-pd1- therapy (in case of msi/mmrd) . (exception: patients who have received mfolfoxiri +/- anti-vegf or anti- egfr- 1l therapy or patients with ineligibility to receive 5-fu, oxaliplatin or irinotecan can be included after 1st line.) exclusion criteria: * due to the non-interventional design of this registry, there are no specific exclusion criteria

Keywords: colorectal
non-pharmacological interventions on sleep in post-acute rehabilitation

Conditions: Sleep Disorders

Summary: this project is a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people undergoing post-acute rehabilitation.

the purpose of this study is to perform a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people (n = 214) undergoing post-acute rehabilitation. the intervention will combine: 1) structured sleep assessment, 2) patient education in key elements of cognitive behavioral strategies to improve sleep, and 3) environmental interventions on factors which likely contribute to abnormal sleep/wake patterns in the post-acute rehabilitation setting. this project will be conducted in a va post-acute rehabilitation site. older veterans (\>= 60 years) who were previously community-dwelling (n = 214) will be randomized to receive the intervention, or a social contact and memory skills training program as the control condition. data collected at baseline will include medical data and demographics, as well as subjective and objective measures of sleep, structured assessments of functional status, and medical comorbidity. follow-up assessments will be performed in the facility while the intervention/control condition is in place, and at three months and six months after discharge from rehabilitation. the main outcome measures will include objective sleep measures (nighttime percent sleep and daytime percent sleep) and functional status collected at three and six months follow-up. data will be analyzed for all randomized participants in an intention to treat analysis.

Eligibility criteria:
inclusion criteria: * adults aged \> or = 60, who are admitted to inpatient rehabilitation services, who lived in a non-institutional setting prior to admission, and are admitted for rehabilitation exclusion criteria: * severe sleep apnea * severe cognitive impairment * not enrolled within one week of admission to rehabilitation unit * too ill to participate * and planned discharge to a nursing home for total nursing care

Keywords: sleep disorders rehabilitation rehabilitation outcomes
comparison between glp 1 analogues and dpp 4 inhibitors in type 1 diabetes mellitus

Conditions: Type 1 Diabetes

Summary: to study the effects of glp 1 analogues and dpp 4 inhibitors on newly detected type 1 diabetes patients.

inclusion criteria t1dm \ 30 yr pancreatic disease significant systemic complication

Eligibility criteria:
inclusion criteria: * t1dm \<3 months * gad antibody+ or stimulated c peptide\<0.5 ng/ml * ketosis at onset * age \< 30 yr exclusion criteria: * age \> 30 yr * pancreas disease * significant systemic disease

Keywords: type 1 diabetes exenatide sitagliptin
estimating ec95 of remifentanil for cough prevention during emergence from total intravenous anesthesia with propofol and remifentanil in patients undergoing transsphenoidal hypophysectomy

Conditions: Hypophysectomy

Summary: in patients undergoing hypophysectomy through transsphenoidal approach, preventing cough during anesthetic emergence is important to avoid hemorrhage and cerebrospinal fluid leakage. previous reports demonstrated that administration of remifentanil during anesthetic emergence could reduce the incidence and severity of cough during anesthetic emergence. therefore, the objective of this study is to determine ec95 of remifentanil for preventing cough during anesthetic emergence in patients undergoing hypophysectomy with transsphenoidal approach.


Eligibility criteria:
inclusion criteria: * scheduled to undergo hypophysectomy with transsphenoidal approach * american society of anesthesiologists physical status i or ii * more than 20 years old exclusion criteria: * acute or chronic respiratory disease * uncontrolled hypertension * taking sedatives or anti-tussive * gastro-esophageal reflux * pregnant or breast feeding * patients who cannot understand statements for subjects or this study itself

Keywords: ec95, effective concentration in 95% of subjects
effect of taurine on portal hemodynamics in patients with advanced liver cirrhosis

Conditions: Cirrhosis; Portal Hypertension

Summary: the investigators want to analyze the effect of taurin on portal hemodynamics in patients with advanced liver cirrhosis.

28 days of 6 grams taurine versus placebo (randomization 1:1).

Eligibility criteria:
inclusion criteria: * patients (male and female) aged older than 18 years with advanced liver cirrhosis (child's grade b and child's grade c), regardless of the disease origin (viral, alcoholic, idiopathic), who are scheduled for hepatic hemodynamic investigation * negative pregnancy test of women with childbearing potential * patient without beta blocker therapy: due to: intolerance of the medication, preexisting contraindication against beta blocker therapy, endoscopic band ligation as prophylaxis exclusion criteria: * history of variceal bleeding without endoscopic band ligation * history of endoscopically diagnosed large varices with red spots without previous bleeding and without endoscopic band ligation * hvpg \< 10 mmhg * hvpg \> 20 mmhg and varices, unless ligated and treated in an eradication program within 6 months * beta blocker therapy * history of hypersensitivity to the trial drugs and contrast agent or to drugs with similar chemical structure * treatment with vasoactive or non-steroidal anti-inflammatory drugs or systematic antibiotics one week before the study * exclusion criteria for hepatic hemodynamic investigation * cardiac, renal or respiratory failure * previous surgical or transjugular intrahepatic portosystemic shunt * breast-feeding or pregnant women

Keywords: cirrhosis portal hypertension taurin
antibiotic prophylaxis in rectal cancer surgery: oral with intravenous versus intravenous antibiotics.

Conditions: Rectal Cancer

Summary: this is a randomized, controlled, parallel study to determine the efficiency of oral antibiotics in reduction of surgical site infection (ssi) in rectal cancer surgery.

patients undergoing rectal cancer surgery in a single centre will assigned randomly to combined preoperative oral antibiotics (metronidazole and erythromycin) and perioperative intravenous antibiotics (cefmetazole) (oral+intravenous group) or to perioperative intravenous antibiotics (cefmetazole) alone (intravenous group). the primary endpoint is the overall rate of ssi.

Eligibility criteria:
inclusion criteria: * have a planned of resection of rectum * have signed approved informed consent form for the study. exclusion criteria: * significant simultaneous surgical procedure (e.g., liver resection of metastasis) * bacterial infection at the time of surgery or antimicrobial therapy up to 4 weeks before surgery * preoperative severe impairment in renal function (creatinine clearance (mdrd) \< 30 ml/min) * allergy on the study drugs .

Keywords: surgical site infection rectal cancer surgery oral antibiotic antibiotic prophylaxis
biomarker 11-dh-txb2 in blood and urine samples from patients with prostate cancer and healthy volunteers

Conditions: Prostate Cancer

Summary: rationale: studying samples of blood and urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. purpose: this research study is looking at a biomarker, 11-dh-txb2, in blood and urine samples from patients with prostate cancer and healthy volunteers.

objectives: * to identify a potential novel marker of prostate cancer in the blood and urine, 11-dh-txb2, to be used as a screening tool for prostate cancer as well as in detection of early relapse in patients previously treated for early-stage prostate cancer. outline: blood and urine samples are collected and analyzed for plasma and urinary 11-dh-txb2 levels by hplc and tandem-mass spectrometry.

Eligibility criteria:
disease characteristics: * meets one of the following criteria: * histopathologically confirmed prostate cancer meeting 1 of the following criteria: * newly diagnosed untreated disease * received prior local therapy (prostatectomy, definitive radiotherapy, brachytherapy, or cryotherapy) with no evidence of disease activity (defined as serum psa \< 0.4 ng/ml post therapy) and by imaging studies * experienced biochemical failure (defined as rise in serum psa ≥ 0.4 ng/ml post therapy) * healthy volunteer (clinic patient with no history of clinically significant malignancies within the past 6 months) patient characteristics: * no clinical evidence of liver cirrhosis or chronic liver disease (i.e., evidence of ascites or severe coagulopathy) * no active prostatitis prior concurrent therapy: * see disease characteristics * more than 30 days since prior and no concurrent regular antiplatelet agents (including aspirin, anagrelide, cilastazole, clopidogrel, dipyridamole, pentoxiphylline, sulfinpyrazone, or ticlopidine) * more than 7 days since prior and no concurrent nsaids (including ibuprofen, celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, indomethacin, ketoprofen, meclofenamate, mefenamic acid, nabumetone, naproxen, oxaprozin, piroxicam, sulindac, or tolmetin)

Keywords: recurrent prostate cancer stage i prostate cancer stage ii prostate cancer stage iii prostate cancer stage iv prostate cancer
twynsta study with lifestyle modifications in korean patients with hypertension

Conditions: Hypertension

Summary: this observational study is designed to evaluate the effects of twynsta tablets with life style modifications on blood pressure, quality of life, and other risk factors in korean patients with hypertension in a routine clinical practice setting.

study design:

Eligibility criteria:
inclusion criteria: 1. patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine or telmisartan monotherapy (=140/90 mmhg, = 130/80 mmhg for those with diabetes or kidney disease) 2. age = 19 years at enrollment 3. male or female patient (or legally acceptable representative) willing and able to provide written informed consent exclusion criteria: 1. patients with previous exposure to twynsta 2. patients with hypersensitivity to the active substances, or to dihydropyridine derivatives 3. female patients at second and third trimesters of pregnancy 4. female patients with lactation 5. patients with biliary obstructive disorders 6. patients with severe hepatic impairment 7. patients with high grade aortic stenosis 8. patients with shock 9. patients with hereditary conditions such as intolerance with excipient of the products 10. current participation in other clinical trials or observational studies
"cupping therapy combined with conventional physical therapy improves pain and health related quality of life among female patients of low back pain''

Conditions: Low Back Pain

Summary: a randomized control trial will be done on diagnosed low back pain patients in fauji foundation hospital rawalpindi. there is a growing interest and demand in the field of complementary and alternative medicine(cam), nowadays .the purpose of the study is to determine the effects of cupping therapy combined with conventional physical therapy to exercise to lower the pain and improve the health related quality of life of the patient using the modified sf - 36 scale. the conventional physical therapy includes hot pack placed on the low back region for ten minutes, interferential current therapy was used which has four round electrodes measuring 2.75 inches placed on the desired area(low back) waveform used was ifc- 4p , having a carrier frequency of 4000 hz and a frequency of 80/150 hz, vector scan was off , the intensity was increased manually according to the capacity of the patient and the treatment time was 15 minutes, strenghtening exercises such as william flexion were done once in the rehabilition center and patient was given a home plan to follow twice daily with 15 repitions each.

experimental group (a) = this group will receive cupping therapy every month combined with conventional physical therapy whhich includes hot pack , interferential therapy and streghtening exercises for back and their outcomes wi;; be measured at baseline and at the end of 6th month treatment.. control group (b) =this group will not receive cuppping therapy , only conventional physical therapy will be given and their outcomes will be observed at the baseline and then after treatment of 06 months. data analysis techniques: the data will be analyzed through spss 21 and data would be analyzed based on the study design chosen that is random control experimental study within the community using the vas scale. a printed questionnaire will be provided to the parents after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables. significance of the study: this study will make people become aware of their current physical fitness level, so the lifestyle behaviors can be modified if needed, in order to improve their quality of life this study will help create awareness among the people, it is not only economically accessible but also have very little chances of side effects this study will open new doors for researchers to do long term studies on different types of pain with different exercise types.

Eligibility criteria:
inclusion criteria: 1. female population of age between 30 to 50 years. 2. female patients with diagnosed low back pain. exclusion criteria: female population with cardiological, neurological, circulatory and orthopedic problems opens wounds or bone fractures.
carbohydrate loading and diabetes in colorectal surgery

Conditions: Diabetes Mellitus, Type 2; Surgery; Surgery--Complications

Summary: the goal of this study is to evaluate the feasibility of conducting a large study that would assess the safety of carbohydrate drinks (i.e. juice) prior to elective colorectal surgery in patients with type 2 diabetes. traditionally, prior to surgeries involving a general anesthetic, patients have been told not to eat or drink anything after midnight due to the risk of aspiration. more recent research have shown that it is safe to have clear fluids up to 2 hours before an operation and this is reflected in the current anesthesia clinical guidelines. moreover, it has been shown that subjecting patients to a state of starvation causes stress on the body that may lead to complications such as poor wound healing, infections, and delayed return to bowel function. a sugar drink before surgery has been shown to be beneficial and can lead to decreased complication rates and decreased length of stay after surgery. however, it is currently not known if it is safe for patients with type 2 diabetes to have a sugar drink before their surgery since they have trouble processing sugars and a subset of patients with diabetes are at increased risk of aspiration due to delayed stomach emptying. this feasibility study is designed to answer the question of whether a large scale trial can be conducted examining the benefits of a pre-operative sugar drink in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * all adult (\>=18 years of age) patients with an established diagnosis of type 2 diabetes mellitus undergoing elective colorectal surgery at the university of alberta hospital, the grey nuns hospital, the royal alexandra hospital or the misericordia hospital will be eligible. only patients treated with diet or oral hypoglycemic agents will be included. exclusion criteria: * subjects \<18 years of age, and those on insulin therapy preoperatively will be excluded.